Intended purpose of use: inject fluids into, of withdraw fluids from, the body
Product Description:
Syringe, two pieces: barrel with Luer Lock nozzle and piston of three pieces barrel with luer nozzle, piston and stopper.
Without needle.
Capacity: 20 ml.
Graduated scale on the barrel with 1.0 ml (minor) and 5.0 ml (major) increment lines.
Barrel sufficiently transparent to allow easy measurement of the volume contained in the syringe and detection of air bubbles.
Materials for barrel and piston: medical grade plastic (Polyethylene (PE)/ polypropylene (PP)/ polystyrene (PS).
The Luer Lock nozzle shall be situated centrally.
plunger tip: the three part syringes end in a synthetic elastomer plunger tip of gasket, flat of dome shaped ensuring a perfect plunger barrel seal integrity and a flawless gliding behaviour.
Sterile and disposable.
Single use.
Sterilization method: Ethylene oxide.
Shelf life 5 years
Supplied with:
Manufacturer's instruction for use, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Accessories / Spare Parts / Consumables (available but not supplied):
N/A
Intended use:
Syringe is used with an injection needle with compatible luer fitting.
Injection safety:
The syringe is sterile, ready for immediate use and is for single use ONLY.
Check the integrity of the packaging before opening.
Do not use the syringe if the package integrity is compromised.
Packaging and Labelling: shall be as per regulations applied to the device
Primary packaging:
One (1) syringe packed in an individual sterilised peel-pack made of paper and/of plastic.
Secondary packaging:
One (1) carton box of hundred (100) syringes to blister packs.
Primary package label includes:
Device identity and intended purpose.
Manufacturer's product code of reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD and EXP.
Any residual device risks, warnings, limitations of contraindications.
Symbols used according ISO 15223.
CE mark.
The word "sterile" (of equivalent harmonised symbol).
Sterilisation method (of equivalent harmonised symbol).
The words "for single use" (of equivalent harmonised symbol).
The words "check the package integrity before use", of similar warning.
The words "destroy after use", if space allows.
Secondary package label includes the number of units.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class Is device
Environmental Requirements:
ISO 14001: Environmental management systems
Product Description:
Syringe, two pieces: barrel with Luer Lock nozzle and piston of three pieces barrel with luer nozzle, piston and stopper.
Without needle.
Capacity: 20 ml.
Graduated scale on the barrel with 1.0 ml (minor) and 5.0 ml (major) increment lines.
Barrel sufficiently transparent to allow easy measurement of the volume contained in the syringe and detection of air bubbles.
Materials for barrel and piston: medical grade plastic (Polyethylene (PE)/ polypropylene (PP)/ polystyrene (PS).
The Luer Lock nozzle shall be situated centrally.
plunger tip: the three part syringes end in a synthetic elastomer plunger tip of gasket, flat of dome shaped ensuring a perfect plunger barrel seal integrity and a flawless gliding behaviour.
Sterile and disposable.
Single use.
Sterilization method: Ethylene oxide.
Shelf life 5 years
Supplied with:
Manufacturer's instruction for use, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Accessories / Spare Parts / Consumables (available but not supplied):
N/A
Intended use:
Syringe is used with an injection needle with compatible luer fitting.
Injection safety:
The syringe is sterile, ready for immediate use and is for single use ONLY.
Check the integrity of the packaging before opening.
Do not use the syringe if the package integrity is compromised.
Packaging and Labelling: shall be as per regulations applied to the device
Primary packaging:
One (1) syringe packed in an individual sterilised peel-pack made of paper and/of plastic.
Secondary packaging:
One (1) carton box of hundred (100) syringes to blister packs.
Primary package label includes:
Device identity and intended purpose.
Manufacturer's product code of reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD and EXP.
Any residual device risks, warnings, limitations of contraindications.
Symbols used according ISO 15223.
CE mark.
The word "sterile" (of equivalent harmonised symbol).
Sterilisation method (of equivalent harmonised symbol).
The words "for single use" (of equivalent harmonised symbol).
The words "check the package integrity before use", of similar warning.
The words "destroy after use", if space allows.
Secondary package label includes the number of units.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class Is device
Environmental Requirements:
ISO 14001: Environmental management systems
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.08 |
| Pack of 50 | $2.88 |
| Pack of 100 | $7.69 |
